Clinical trials: Gastroenteritis
Rotavirus Gastroenteritis
Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam
An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam
- Trial name
- NCT04596696
- Testing
- Rotavac
- Where
- Vietnam
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Diarrhea
Shigella WRSS1 Vaccine Trial in Bangladesh
This is a research study of an experimental (investigational) live attenuated Shigella sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune response.
- Trial name
- NCT02934178
- Testing
- Shigella sonnei Strain WRSS1 Vaccine
- Where
- Bangladesh
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- PATH
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least…
- Trial name
- NCT00750893
- Testing
- Rotarix or Rotarix liquid formulation
- Where
- South Korea
- Volunteers
- 3,111 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Dehydration, Acute Gastroenteritis
Comparing Speedlyte and IV Rehydration Treating Children With Gastroenteritis in a Pediatric Emergency Department (ED)
To compare length of stay (LOS) of pediatric patients in a pediatric emergency room presenting with Gastroenteritis treated with IV rehydration versus oral Speedlyte rehydration.
- Trial name
- NCT03562702
- Testing
- Standard IV Rehydration Therapy, Oral Rehydration Therapy (ORT)
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Infections, Rotavirus, Rotavirus Vaccines
Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants
The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.
- Trial name
- NCT00969228
- Testing
- Rotarix ™
- Where
- 18 sites in South Korea
- Volunteers
- 684 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus, Rotavirus Vaccines
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.
- Trial name
- NCT00432380
- Testing
- Rotarix™
- Where
- Philippines
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Gastroenteritis
Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis
This study evaluates a new drug, new enteroadsorbent polymethylsiloxane (Enterosgel) in the treatment of rotavirus gastroenteritis in children.
- Trial name
- NCT04116307
- Testing
- Polymethylsiloxane, Lactobacillus reuteri
- Where
- Croatia
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- University Hospital for Infectious Diseases, Croatia
Diarrhea
The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection
The existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, targeted to impact on the immediate clinical symptoms upon E. coli infection.
- Trial name
- MIRRE (NCT03596827)
- Testing
- E. coli strain E1392-75-2A dose 1E10 CFU, E. coli strain E1392-75-2A dose 1E9 CFU, E. coli strain E1392-75-2A dose 1E8 CFU
- Where
- Netherlands
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- NIZO Food Research
Dehydration
IV Glucose for Dehydration Treatment
To determine whether the addition of dextrose to IV fluids in the treatment of gastroenteritis leads to a decrease in serum ketones.
- Trial name
- NCT01285713
- Testing
- 5% Dextrose (D5) in Normal Saline (NS), Normal Saline (NS)
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Clinical Infection, Microbial Colonization
Effect of Gut Microbiota and Fecal Inflammatory Marker on Childhood Gastroenteritis
Childhood gastroenteritis establishes gastrointestinal disease and increase the economic burden, and the pediatric population is especially vulnerable to these gastrointestinal infections.
- Conditions
- Clinical Infection, Microbial Colonization, Gastroenteritis, Inflammatory Response
- Trial name
- NCT03856138
- Where
- Taiwan
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Diarrhea
Safety Study of Live Attenuated Oral Shigella (WRSS1) Vaccine in Bangladeshi Adults and Children
This is a research study about an experimental (investigational) oral Shigella sonnei - Walter Reed S. sonnei (WRSS1). WRSS1 is a live vaccine that is being made to prevent disease from Shigella, which causes bloody, watery…
- Trial name
- NCT01813071
- Testing
- WRSS1
- Where
- Bangladesh
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- PATH
Diarrhea
Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan
The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan.
- Trial name
- NCT02047162
- Testing
- Bismuth subsalicylate
- Where
- Pakistan
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Gastroenteritis Escherichia Coli
Safety of Sublingual dmLT for ETEC
A Phase 1 dose escalating study of ETEC candidate vaccine to determine safety and immunogenicity of a multi-dose regimen in healthy adult volunteers.
- Trial name
- NCT02052934
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gastroenteritis Norovirus
Optimal Human Dose for GII.2 Norovirus (Snow Mountain) Challenge Studies
This is a phase I, randomized, double blind, as well as partially blinded (for Cohort 4), placebo-controlled safety, illness, and infection study of a new experimental human challenge stock of the Norovirus genogroup II, genotype…
- Trial name
- NCT02473224
- Testing
- Norovirus GII.2 Challenge
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Rotavirus Gastroenteritis
Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants.
- Trial name
- NCT02062385
- Testing
- V260, OPV, DTaP
- Volunteers
- 4,040 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Gastroenteritis
Bivalent Norovirus Vaccine Study
Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3 compared to controls.
- Trial name
- NCT01168401
- Testing
- NoV GI.1/GII.4 Bivalent VLP Vaccine, Saline
- Where
- 3 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Takeda
Rotavirus Gastroenteritis
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)
A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants.
- Trial name
- NCT01600092
- Testing
- RotaTeq™ experimental formulation, RotaTeq™ existing formulation
- Volunteers
- 1,020 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus Gastroenteritis
Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization
This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).
- Trial name
- NCT02584816
- Testing
- BRV-PV Lot A + DPT-HepB-Hib + OPV, BRV-PV Lot B + DPT-HepB-Hib + OPV, BRV-PV Lot C + DPT-HepB-Hib + OPV
- Where
- 10 sites in India
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Rotavirus Gastroenteritis
A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.
- Trial name
- NCT02133690
- Testing
- Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)
- Where
- 6 sites in India
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Rotavirus Gastroenteritis
Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India
This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of…
- Trial name
- NCT03474055
- Testing
- Liquid Rotavirus Vaccine
- Where
- 8 sites in India
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.